The Trump administration’s proposed cuts at the National Institutes of Health and Food and Drug Administration could lower ...

Aldeyra Therapeutics (NASDAQ:ALDX) announced on Thursday that the U.S. Food and Drug Administration (FDA) accepted for review ...

The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...

An FDA advisory panel will meet July 18 to consider a supplemental new drug application for the antipsychotic brexpiprazole, ...

The new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed ...

Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of ...

A new report looks at hiring trends © 2025 American City Business Journals. All rights reserved. Use of and/or registration ...

Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease November 29, 2022 08:00 AM ...

Achieve Life Sciences, Inc. has submitted a New Drug Application (NDA) to the U.S. FDA for cytisinicline, which, if approved, would be the first new pharmacotherapy for nicotine dependence in 20 ...

The application is supported by data from 2 randomized, open-label, multicenter phase 3 clinical studies (NCT04292730 and NCT04292899) conducted by Gilead and a randomized, placebo-controlled ...

First-ever drug application for MDMA finally reaches FDA after near 40-year journey By Max Bayer Dec 13, 2023 9:39am ...

A new drug application is anticipated for 2029. The investigational new drug application for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis has been cleared by the FDA, ...